declaration of ce conformity declaration of ce conformity
Contents
1. DECLARATION OF CE CONFORMITY FARO S p A Via Faro 15 20060 Ornago Milano ITALY The manufacturer declares under its own responsability that following product Product name Dental Practice Micromotor Model in the version Unica It is factory new in accordance with the provisions of art 6 para 2 of D L 626 94 It fully conforms to the following European directives and national acceptances 93 42 CEE medical devices directive Class which the equipment belongs to Ia It conforms to the following standards CEI EN 60601 1 EN 50011 CEI 110 6 Dott Angelo Favonio Managing Director 23 DECLARATION OF CE CONFORMITY FARO S p A Via Faro 15 20060 Ornago Milano ITALY declares under its own responsability that following product The manufacturer Product name Dental Practice Micromotor Model in the version Unica It is factory new in accordance with the provisions of art 6 para 2 of D L 626 94 It fully conforms to the following European directives and national acceptances 93 42 CEE medical devices directive Class which the equipment belongs to Ia It conforms to the following standards CEI EN 60601 1 EN 50011 CEI 110 6 Dott Angelo Favonio Managing Director 23 TABLE OF CONTENTS e Symbols used in this manual page 25 e Safety rules page 26 27 e Features page 28 22. Use small screwdriver as lever on light bulb base and withdraw it from its housing e Fit new light bulb without touching it with fingers To clean light bulb use cloth dampened with alcohol Return case A to original position taking care to position reference pin B in its seat C 39 TROUBLESHOOTING Micromotor leaks Check O rings on handpiece coupling and replace them if necessary see water or air page 37 fig 3 In case of difficulty call our Service Department Micromotor does not Check brushes and replace them if necessary see page 38 fig 4 run In case of difficulty call our Service Department Light bulb does not Check light bulb condition and replace it if defective see page 39 fig 5 light Apply only to FARO Service Centers for parts and service 40 DATA SHEETS 20 000 and 40 000 rpm External spray and Intramatic versions Rotation speed Power supply Maximum current absorbed Power output Maximum torque at shaft Stalling torque Air consumption at handpiece at 2 5 bar Spray water consumption at 2 bar Motor cooling air consumption at 2 5 bar Intermittent operation Weight from 1 200 to 20 000 and from 2 500 to 40 000 rpm from 2 to 24 V d c 1 8 A 17 5 W 20 000 rpm 27 W 40 000 rpm 1 7 Nem 20 000 rpm 0 81 Nem 40 000 rpm 4 8 Nem 20 000 rpm 6 Nem 40 000 rpm 4 67 l min 160 ml min 20 000 rpm 40 000 r
3. free of charge No compensation for damages and or interest will be recognized The guarantee is not deemed valid in the final judgment of FARO in case of tampering damage incorrect use faulty maintenance or normal wear The guarantee does not cover light bulbs and fuses 43
4. 9 e Description of parts page 30 31 32 e Installation pag 33 34 e Operating instructions page 35 e Maintenance pag 36 37 38 39 e Troubleshooting page 40 e Data sheets page 41 42 e Guarantee certificate page 43 24 SYMBOLS USED IN THIS MANUAL Danger Prohibition The paragraphs marked with this symbol contain This icon identifies what to prevent doing instructions to be followed carefully to avoid to avoid damage to the device damage to the device the operator and the patient Warning Q Suggestions These instructions warn to be very careful to With this icon information is supplied avoid situations which could damage the device permitting more effective use of the device 25 SAFETY RULES e Device of class II e Device of type B e Follow all instructions set forth in this manual e This device is to be used in a dental practice only by medical personnel e To avoid cross contamination between patients fit the device to or remove it from handpiece taking care to avoid contact with hands or contaminated gloves e The device is not suitable for use in presence of anesthetic mixtures inflammable with air oxygen or nitrous oxide The device is not protected against liquids penetration e The device is not delivered sterilized therefore it must be cleaned before use see page 36 e The device is not sterilizable 26 e The device does not require lubrication e A denta
5. l practice hanpiece in conformity with ISO 3964 is connected to device The device is connected to a Faro cable e To operate safely this device should be used with FARO electronic circuit e Never attempt any maintenance on electrical part when cable is connected Do not attempt to repair either the device or associated electronic circuit e Only perform operations described in this manual In all other cases apply to our Service Department e When the equipment is packed it can lie 15 weeks to environmental conditions that do not exceed the following ranges gt Surrounding temperature of 20 C 4 F or 70 C 4 158 F Relative humidity from 10 to 90 Atmospheric pressure from 500 to 1060 mBar e The micromotor must be powered in conformity with CEI EN 60601 1 2T FEATURES The device is an electrical Micromotor which supplies kinetic energy to a handpiece fit on its end It also supplies light eneergy in INTRALUX M 40 L version with a light bulb installed into the device UNICA Micromotor is produced in the following versions 20000 rpm with external spray 20000 rpm Intramatic 40000 rpm with external spray 40000 rpm Intramatic 40000 rpm Intramatic with light INTRALUX M 40 L 28 e Dental practice micromotors of UNICA series are designed to give a safe and at the same time an ergonomic grip without irregular surfaces e A single cable powers all versio
6. ns of the UNICA series including versions with light e Micromotors of the UNICA series are designed to supply kinetic energy to a handpiece not provided fit on its end In its various versions the device allows passage of water and air for cooling spray on burr It also supplies light to handpieces with optical fiber 29 DESCRIPTION OF PARTS 1 Handpiece coupling 20000 or 40000 rpm Micromotor with external spray internal mixing 2 Spray tube 3 Micromotor body 30 DESCRIPTION OF PARTS 1 Handpiece coupling A 2 O ring 20000 or 40000 rpm Micromotor Intramatic 3 Mie moor Keay 4 Air 5 Water 31 DESCRIPTION OF PARTS 1 Handpiece coupling 40000 rpm Micromotor Intramatic with light Oring 3 Micromotor body INTRALUX M 40 L 4 Ai ir 5 Water 1 2 4 3 6 Light bulb 7D EF 5 6 32 INSTALLATION Check to make sure the following items are received e Dental practice micromotor in the requested version e Tubes for external spray versions e Pins e O rings for Intramatic versions e Operating manual 33 THE DEVICE CAN BE INSTALLED BY USER e Fit micromotor in the base of cable Screw down ringnut of cable to micromotor clockwise 34 OPERATING INSTRUCTIONS After connecting micromotor to cable check if the following operations are performed e Motor turn
7. pm 8 l min 40 000 rpm 1 30 full load 8 time out 98 g external spray or intramatic 41 40 000 rpm Tntralux M 40 L version Rotation speed Power supply Maximum current absorbed Power output Maximum torque at shaft Stalling torque Air consumption at handpiece at 2 5 bar Spray water consumption at 2 bar Motor cooling air pressure Light bulb input voltage Motor cooling air consumption at 2 5 bar Intermittent operation Weight from 2 500 to 40 000 rpm from 2 to 24 V d c 1 8 A 27 W 0 81 Nem 6 Nem 4 67 l min 160 ml min 2 5 bar 3 5 V d c 8 l min 1 30 full load 8 time out 98 g Intralux 42 GUARANTEE CERTIFICATE FARO grants to the final customer a 12 months guarantee starting from the date of the purchase invoice Repairs under the guarantee shall be done at the FARO premises or by an authorized FARO Service person with transportation costs and risks at the expense of the purchaser The guarantee certificate found on the endleaf of this booklet is considered valid only if it is entirely completed and bears the reseller s stamp Repairs under guarantee during the period of effectiveness wil be done only if the article to be repaired is accompanied by the shipping note or purchase invoice The guarantee covers failures due to poor material quality or manufacturing defects and in case of legitimate claim the guarantee will allow repair or replacement
8. s e In external spray version AIR and WATER come out of tube A fig 1 e In Intramatic version AIR comes out of hole B and WATER comes out of hole C fig 2 e In Intralux version light bulb lights After the above checks connect handpiece 35 MAINTENANCE The device must be cleaned after each operation e Before cleaning the device disconnect cable e The device is not protected against liquid penetration e Clean the micromotor including cable with a cloth moistened with disinfectant or non abrasive detergent THE DEVICE IS NOT STERILIZABLE 36 Lubrication In the INTRAMATIC version it is recommended to lubricate the 3 O rings A regularly with vaseline to limit wear and ensure perfect seal of water and air fig 3 Do not lubricate any other mechanical part of micromotor fig 3 37 Replacing brushes To replace brushes proceed as follows fig 4 e Disconnect micromotor from cable by unscrewing rear ringnut e Using special pin remove contact blabe with brush e Clean brush housing with compressed air e Fit new brushes e Connect cable to micromotor and tighten rear ringnut 38 Changing light bulb on version INTRALUX M 40 L To change light bulb proceed as follows fig 5 e Remove external case A in direction of arrow e
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